Label: SPRINJENE NATURAL SENSITIVITY RELIEF- sodium monofluorophosphate and potassium nitrate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 5, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Sodium Monofluorophosphate: 0.76% (0.14% w/v fluoride ion)Anticavity
    Potassium Nitrate: 5%Antihypersensitivity
  • Use

    Helps remove surface stains with regular brushing, and helps prevent plaque buildup.

  • Warnings

    Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Supervise children as necessary until capable of using without supervision. Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day as directed by a dentist or physician. Children 2 to 6 years instruct in good brushing and rinsing habits (to minimize swallowing). Children under 2 years do not use unless directed by a dentist or physician.

  • Inactive Ingredients

    Xylitol, Aqua, Glycerin, Precipitated Natural Calcium Carbonate, Hydrated Silica, Zemea (1,3-Propanediol made from Corn), Potassium Cocoate (made from Coconut Oil), Flavor, Zinc Citrate, Xanthan Gum, Acacia Gum, Zinc Oxide, Black Seed Oil (Nigella sativa), Citric Acid, Stevia

  • Questions or comments?

    Call 1-844-346-2872 www.sprinjene.com

  • SPL UNCLASSIFIED SECTION

    Manufactured and Dist. by Health and Natural Beauty USA Corp.
    Piscataway, NJ 08854

  • PRINCIPAL DISPLAY PANEL - 99 g Tube Carton

    SprinJene®+Sensitivity
    Natural
    Relief

    CAVITY PROTECTION

    TOOTHPASTE

    with Black Seed Oil (Nigella sativa) & Zinc
    Helps Relieve Teeth Sensitivity | Remineralizes Enamel
    Helps Dry Mouth | Cleans Teeth | Freshens Breath

    NET WT 3.5 OZ (99 g)
    Made in USA

    To accommodate
    the needs of
    various lifestyles.

    CERTIFIED VEGAN
    V
    VEGAN.ORG
    Vegan

    GLUTEN-FREE
    ICS
    CERTIFIED
    Gluten
    Free

    U
    Kosher

    HALAL
    Halal

    Certified

    PRINCIPAL DISPLAY PANEL - 99 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SPRINJENE NATURAL   SENSITIVITY RELIEF
    sodium monofluorophosphate and potassium nitrate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63404-1942
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1.5 mg  in 1 g
    Potassium Nitrate (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) Potassium Nitrate50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Calcium Carbonate (UNII: H0G9379FGK)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Propanediol (UNII: 5965N8W85T)  
    Potassium Cocoate (UNII: F8U72V8ZXP)  
    Zinc Citrate (UNII: K72I3DEX9B)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Acacia (UNII: 5C5403N26O)  
    Zinc Oxide (UNII: SOI2LOH54Z)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63404-1942-11 in 1 CARTON07/01/2017
    199 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/01/2017
    Labeler - Health and Natural Beauty USA Corp (079129688)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health and Natural Beauty USA Corp079129688MANUFACTURE(63404-1942)
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